Azithromycin ( DrugBank: Azithromycin )


6 diseases
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎1
84サルコイドーシス4
85特発性間質性肺炎2
96クローン病7
228閉塞性細気管支炎11
299嚢胞性線維症19

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00043264
(ClinicalTrials.gov)
June 20017/8/2002Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple SclerosisAntibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple SclerosisMultiple SclerosisDrug: Rifampin;Drug: AzithromycinNational Center for Research Resources (NCRR)National Multiple Sclerosis SocietyCompleted18 Years65 YearsBoth40Phase 2United States

84. サルコイドーシス


臨床試験数 : 149 薬物数 : 202 - (DrugBank : 78) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 169
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04020380
(ClinicalTrials.gov)
September 6, 201911/7/2019Azithromycin a Treatment for Pulmonary SarcoidosisA Single Arm, Open-label Exploratory Clinical Trial of Azithromycin in Pulmonary SarcoidosisSarcoidosis, PulmonaryDrug: Azithromycin 250Mg CapsuleHull University Teaching Hospitals NHS TrustNULLCompleted18 Years80 YearsAll21Phase 2United Kingdom
2EUCTR2019-000580-24-GB
(EUCTR)
17/05/201925/03/2019A clinical trial of the antibiotic azithromycin for patients with sarcoidosisA single arm, open-label clinical trial of azithromycin in pulmonary sarcoidosis - Azithromycin for sarcoidosis Sarcoidosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Azithromycin
Product Name: Azithromycin
INN or Proposed INN: azithromycin monohydrate
Hull & East Yorkshire Hospitals NHS trustNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United Kingdom
3NCT02024555
(ClinicalTrials.gov)
March 201426/12/2013Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary SarcoidosisInvestigation of the Efficacy of Antimycobacterial Therapy on Pulmonary Sarcoidosis Phase II Randomized, Double-blind, Placebo-controlled TrialSarcoidosis; Antimycobacterial TherapyDrug: Levofloxacin;Drug: Ethambutol;Drug: Azithromycin;Drug: Rifampin;Drug: PlaceboVanderbilt UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed18 YearsN/AAll97Phase 2United States
4NCT01169038
(ClinicalTrials.gov)
July 201022/7/2010Investigation of the Efficacy of Antibiotics on Pulmonary SarcoidosisInvestigation of the Efficacy of Antibiotics on Pulmonary SarcoidosisPulmonary Sarcoidosis;Lung FunctionDrug: levaquin; ethambutol; rifampin and azithromycin.Vanderbilt UniversityNULLCompleted18 Years75 YearsAll15Phase 1United States

85. 特発性間質性肺炎


臨床試験数 : 627 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02173145
(ClinicalTrials.gov)
August 19, 201423/6/2014Azithromycin in Idiopathic Pulmonary FibrosisAzithromycin for the Treatment of Cough in Idiopathic Pulmonary Fibrosis- a Clinical TrialIdiopathic Pulmonary Fibrosis;CoughDrug: azithromycin;Drug: placeboUniversity Hospital Inselspital, BerneUniversity of BernCompleted18 YearsN/AAll27N/ASwitzerland
2NCT01432080
(ClinicalTrials.gov)
September 20118/9/2011Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post AllotransplantDoes Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot StudyRespiratory Tract Infections;Bronchiolitis Obliterans;Cryptogenic Organizing Pneumonia;Lung Diseases, InterstitialDrug: Prednisone;Drug: Azithromycin;Drug: Montelukast;Drug: SymbicortMaisonneuve-Rosemont HospitalThe Canadian Blood and Marrow Transplant GroupTerminated18 YearsN/AAll12Phase 2Canada

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04186247
(ClinicalTrials.gov)
August 13, 20212/12/2019Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)Personalized AZithromycin/metronidAZole, in Combination With Standard Induction Therapy, to Achieve a Fecal Microbiome Community Structure and Metagenome Changes Associated With Sustained Remission in Pediatric Crohn's Disease (CD): a Pilot StudyCrohn Disease;Pediatric Crohns DiseaseDrug: Azithromycin;Drug: Metronidazole;Other: Standard of CareUniversity of North Carolina, Chapel HillCrohn's and Colitis Foundation;University of AmsterdamRecruiting3 Years17 YearsAll20Phase 2United States;Canada;Israel;Netherlands
2EUCTR2019-004219-29-NL
(EUCTR)
21/04/202004/02/2020Personalized antibiotic therapy in combination with standard therapy to achieve a fecal profile associated with prolonged complaint-free period in pediatric Crohn’s DiseasePersonalized AZithromycin/metronidAZole, in combination with standard induction therapy, to achieve a fecal microbiome community structure and metagenome changes associated with sustained remission in pediatric Crohn’s Disease (CD): a pilot study” - PAZAZ Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Azithromycin
Product Name: Azithromycin
INN or Proposed INN: Azithromycin
Other descriptive name: AZITHROMYCIN
Trade Name: Metronidazole
Product Name: Metronidazole
INN or Proposed INN: METRONIDAZOLE
Other descriptive name: METRONIDAZOLE
Amsterdam UMCNULLNot RecruitingFemale: yes
Male: yes
20Phase 2United States;Canada;Israel;Netherlands
3EUCTR2012-005226-29-PL
(EUCTR)
16/01/201419/09/2013Antibiotic therapy for children with active Crohn's diseaseAzithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: azithromycin
Trade Name: metronidazole
Product Name: metronidazole
Product Name: azithromycin
Product Name: azithromycin
Erasmus MCHospital S. Joao;University hospital Brussel;Jagiellonian University Medical CollegeNot RecruitingFemale: yes
Male: yes
70Portugal;United States;Canada;Belgium;Poland;Israel;Netherlands
4EUCTR2012-005226-29-PT
(EUCTR)
20/12/201324/09/2013Antibiotic therapy for children with active Crohn's diseaseAzithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: azithromycin
INN or Proposed INN: azithromycin
Other descriptive name: AZITHROMYCIN
Trade Name: metronidazole
Product Name: metronidazole
INN or Proposed INN: METRONIDAZOLE
Other descriptive name: Metronidazole
Centro Hospitalar de São João E.P.E.NULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Portugal;Canada;Poland;Belgium;Israel;Netherlands
5EUCTR2012-005226-29-BE
(EUCTR)
26/04/201314/03/2013Antibiotic therapy for children with active Crohn's diseaseAzithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: azithromycin
Trade Name: metronidazole
Product Name: metronidazole
Wolfson Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Portugal;United States;Canada;Poland;Belgium;Israel;Netherlands
6NCT01596894
(ClinicalTrials.gov)
October 201212/4/2012Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's DiseaseA Randomized, Single Blinded, Controlled, Multi Center Phase 4 Study for Induction of Remission in Active Pediatric Crohn's Disease, Using 2 Months Antibiotic Course of Azithromycin Combined With Metronidazole vs. Metronidazole Alone.Crohn's DiseaseDrug: Azithromycin + Metronidazole;Drug: MetronidazoleProf. Arie LevineNULLCompleted5 Years17 YearsAll73Phase 4Israel
7EUCTR2012-005226-29-NL
(EUCTR)
08/03/2013Antibiotic therapy for children with active Crohn's diseaseAzithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: azithromycin
Trade Name: metronidazole
Product Name: metronidazole
Wolfson Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70United States;Canada;Israel;Netherlands

228. 閉塞性細気管支炎


臨床試験数 : 97 薬物数 : 118 - (DrugBank : 32) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 156
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01959100
(ClinicalTrials.gov)
February 20147/10/2013Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell TransplantationEvaluation of the Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell TransplantationMalignant Hematological DiseasesDrug: Azithromycin;Drug: PlaceboAssistance Publique - Hôpitaux de ParisNULLActive, not recruiting16 YearsN/AAll480Phase 3France
2EUCTR2013-000499-14-FR
(EUCTR)
30/08/201325/09/2015N/AN/A - ALLOZITHRO
MedDRA version: 18.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855
Trade Name: AZITHROMYCINE 250 mg
Product Name: AZITHROMYCINE 250 mg
INN or Proposed INN: AZITHROMYCINE
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
Phase 3France
3EUCTR2012-003331-32-BE
(EUCTR)
18/06/201312/11/2012A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATIONA PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION EARLY LUNG ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION
MedDRA version: 14.1;Level: LLT;Classification code 10050437;Term: Prophylaxis against heart and lung transplant rejection;System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1;Classification code 10016547;Term: FEV;System Organ Class: 10022891 - Investigations
MedDRA version: 14.1;Classification code 10050433;Term: Prophylaxis against lung transplant rejection;Classification code 10006414;Term: Bronchial biopsy abnormal;Classification code 10025041;Term: Lung biopsy abnormal;Classification code 10016549;Term: FEV 1 abnormal;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10025127;Term: Lung transplant;Classification code 10049237;Term: Acute cellular rejection;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1;Classification code 10066543;Term: Acute allograft rejection;Classification code 10039008;Term: Reversible airways obstruction NOS;Classification code 10019319;Term: Heart-lung transplant rejection;Level: LLTClassi;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Azithromycin (Zitromax°)
Product Name: Zitromax
Product Code: not applicable
INN or Proposed INN: AZITHROMYCIN
Other descriptive name: AZITHROMYCIN
KULeuven and University Hospitals LeuvenNULLNot RecruitingFemale: yes
Male: yes
60Phase 4Belgium
4NCT01432080
(ClinicalTrials.gov)
September 20118/9/2011Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post AllotransplantDoes Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot StudyRespiratory Tract Infections;Bronchiolitis Obliterans;Cryptogenic Organizing Pneumonia;Lung Diseases, InterstitialDrug: Prednisone;Drug: Azithromycin;Drug: Montelukast;Drug: SymbicortMaisonneuve-Rosemont HospitalThe Canadian Blood and Marrow Transplant GroupTerminated18 YearsN/AAll12Phase 2Canada
5NCT01307462
(ClinicalTrials.gov)
June 20111/3/2011Targeted Therapy of Bronchiolitis Obliterans SyndromeFluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell TransplantBronchiolitis ObliteransDrug: fluticasone propionate;Drug: montelukast sodium;Drug: azithromycinStephanie LeeNational Cancer Institute (NCI)Completed6 Years99 YearsAll36Phase 2United States
6NCT01327625
(ClinicalTrials.gov)
March 201131/3/2011Efficacy Study of Azithromycin-based Therapy for Bronchiolitis ObliteransA Pilot Study Evaluating the Efficacy of Azithromycin, N-acetylcystein and Inhaled Corticosteroid Combination Therapy for Bronchiolitis Obliterans After Allogeneic Hematopoietic Cell TranspantationGraft vs Host Disease;Bronchiolitis ObliteransDrug: azithromycin + N-acetylcystein + inhaled corticosteroidAsan Medical CenterNULLTerminated15 Years75 YearsBoth6N/AKorea, Republic of
7EUCTR2010-018724-16-BE
(EUCTR)
15/04/201007/04/2010A prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tisA prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tis Lymphocytic airway inflammation (so-called Lymphocytic Bronchitis or Bronchiolitis) post-lung transplantation: evolution of airway inflammation (BAL, TBB), pulmonary function, radiology after 3 months, 6 months, 12 months and outcome 2 years (mortality, bronchiolitis obliterans syndrome) after treatment for histologic confirmed lymphocytic bronchi(oli)tis without concurrent acute allograft rejection.
MedDRA version: 12.1;Level: LLT;Classification code 10006414;Term: Bronchial biopsy abnormal
MedDRA version: 12.1;Classification code 10025041;Term: Lung biopsy abnormal
MedDRA version: 12.1;Classification code 10063078;Term: Bronchoalveolar lavage abnormal
MedDRA version: 12.1;Classification code 10049083;Term: Respiratory tract infection NOS
MedDRA version: 12.1;Classification code 10016547;Term: FEV
MedDRA version: 12.1;Classification code 10016549;Term: FEV 1 abnormal
MedDRA version: 12.1;Classification code 10016550;Term: FEV 1 decreased
MedDRA version: 12.1;Classification code 10016553;Term: FEV 1 low
MedDRA version: 12.1;Classification code 10057799;Term: Computerised tomogram thorax abnormal
MedDRA version: 12.1;Classification code 10025127;Term: Lung transplant
MedDRA version: 12.1;Classification code 10056409;Term: Heart and lung transplant
MedDRA version: 12.1;Classification code 10051604;Term: Lung transplant rejection
MedDRA version: 12.1;Classification code 10019319;Term: Heart-lung transplant rejection
MedDRA version: 12.1;Classification code 10029888;Term: Obliterative bronchiolitis
MedDRA version: 12.1;Classification code 10049202;Term: Bronchiolitis obliterans
MedDRA version: 12.1;Classification code 10050433;Term: Prophylaxis against lung transplant rejection
MedDRA version: 12.1;Level: LLTClassification c
Trade Name: Zitromax
Product Name: Zitromax
Product Code: Na
INN or Proposed INN: OTHER SOURCES
Other descriptive name: AZITHROMYCIN DIHYDRATE
KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group)NULLNot RecruitingFemale: yes
Male: yes
20Phase 4Belgium
8EUCTR2005-003893-46-BE
(EUCTR)
03/11/200921/10/2009AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001 - Chronic rejection at 1 and 2 year post-lung transplantation- Mortality at 1 and 2 year post-lung transplantation- Acute rejection rate at 1 and 2 post-lung transplantation- Infection rate at 1 and 2 year post-lung transplantation- Evolution of airway inflammation and pulmonary function during the first and second year post-lung transplantation
MedDRA version: 12.0;Level: LLT;Classification code 10029888;Term: Obliterative bronchiolitis
MedDRA version: 12.0;Classification code 10049202;Term: Bronchiolitis obliterans
MedDRA version: 12.0;Classification code 10068805;Term: Follicular bronchiolitis
MedDRA version: 12.0;Classification code 10019319;Term: Heart-lung transplant rejection
MedDRA version: 12.0;Classification code 10025127;Term: Lung transplant
MedDRA version: 12.0;Classification code 10050433;Term: Prophylaxis against lung transplant rejection
MedDRA version: 12.0;Classification code 10050437;Term: Prophylaxis against heart and lung transplant rejection
MedDRA version: 12.0;Classification code 10051604;Term: Lung transplant rejection
MedDRA version: 12.0;Classification code 10056409;Term: Heart and lung transplant
MedDRA version: 12.0;Classification code 10016547;Term: FEV
MedDRA version: 12.0;Classification code 10016549;Term: FEV 1 abnormal
MedDRA version: 12.0;Classification code 10016550;Term: FEV 1 decreased
MedDRA version: 12.0;Classification code 10016553;Term: FEV 1 low
Trade Name: Zithromax
Product Name: Zithromax
Product Code: NA
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
Other descriptive name: AZITHROMYCIN DIHYDRATE
KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group)NULLNot RecruitingFemale: yes
Male: yes
80Phase 4Belgium
9EUCTR2006-000485-36-GB
(EUCTR)
23/08/200618/09/2006A randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin StudyA randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin Study Post Lung Transplantation Chronic Rejection identified as bronchiolitis obliterans syndrome (BOS)Product Name: AzithromycinNewcastle upon Tyne Hospitals NHS TrustNULLNot RecruitingFemale: yes
Male: yes
64United Kingdom
10NCT01009619
(ClinicalTrials.gov)
September 20056/11/2009Azithromycin in Bronchiolitis Obliterans SyndromeRandomized Double-blind Placebo-controlled Prevention Trial of Azithromycin in Lung Transplantation.Bronchiolitis Obliterans Syndrome;Graft Rejection;Lymphocytic Bronchiolitis;Respiratory InfectionDrug: Azithromycin;Drug: PlaceboKatholieke Universiteit LeuvenUniversity Hospital, Gasthuisberg;Fund for Scientific Research, Flanders, BelgiumCompleted18 YearsN/AAll83Phase 4Belgium
11NCT00563251
(ClinicalTrials.gov)
April 200521/11/2007Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow TransplantationAzithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow TransplantationBronchiolitis Obliterans;Bone Marrow TransplantationDrug: Azithromycin;Drug: Placebo tabletHospital Authority, Hong KongThe University of Hong Kong;PfizerCompleted18 YearsN/ABoth30N/AChina

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05663255
(ClinicalTrials.gov)
March 1, 202315/12/2022Effectiveness of CFTR Modulators According to Co-therapyIs Effectiveness of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Modulators Impacted by Co-therapy? A Population-based Comparative Effectiveness Study Using Data From French Cystic Fibrosis Registry Linked to French National Healthcare Insurance DatabaseCystic FibrosisDrug: Discontinuation of respiratory co-therapy (azithromycin, RhDNase, or inhaled antibiotics)Hospices Civils de LyonNULLNot yet recruiting6 YearsN/AAll1990NULL
2ChiCTR2100052906
2022-01-012021-11-06A randomized controlled study of comparing the effect of two azithromycin regimens in reducing exacerbation of non-cystic fibrosisA randomized controlled study of comparing the effect of two azithromycin regimens in reducing exacerbation of non-cystic fibrosis BronchiectasisDaily Azithromycin Group:Azithromycin 250mg QD;Weekly Azithromycin Group:Azithromycin 500mg TIW;Placebo Group:None;The First People' Hospital of JiashanNULLRecruitingBothDaily Azithromycin Group:41;Weekly Azithromycin Group:41;Placebo Group:41;Phase 4China
3EUCTR2016-001440-18-NL
(EUCTR)
30/05/201816/01/2018The influence of cytochrome P450 3A4 inhibitors on serum levels of Ivacaftor in cystic fibrosis patients and healthy subjects.Pharmacokinetic interactions between ivacaftor and cytochrome P450 3A4 inhibitors in cystic fibrosis patients and healthy controls - IACI cystic fibrosis and healthy subjects;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Ivacaftor
Trade Name: claritromycin 500mg film coated tablets
Product Name: Claritromycin
Trade Name: Azithromycin 500 mg film-coated tablet
Product Name: azithromycin
Trade Name: Norvir 100 mg film-coated tablets
Product Name: Norvir
university medical center utrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 4Netherlands
4NCT02677701
(ClinicalTrials.gov)
October 21, 201629/1/2016Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF)TEACH Trial: Testing the Effect of Adding CHronic Azithromycin to Inhaled Tobramycin. A Randomized, Placebo-controlled, Double-blinded Trial of Azithromycin 500mg Thrice Weekly in Combination With Inhaled TobramycinCystic FibrosisDrug: azithromycin;Drug: placebo (for azithromycin);Drug: inhaled tobramycinSeattle Children's HospitalNational Heart, Lung, and Blood Institute (NHLBI);Cystic Fibrosis Foundation;CF Therapeutics Development Network Coordinating CenterCompleted12 YearsN/AAll119Phase 4United States
5NCT02531984
(ClinicalTrials.gov)
August 201521/8/2015The Efficacy of Azithromycin in Treating Children With Non Cystic Fibrosis BronchiectasisOpen Trial With Randomized Withdrawal of Treatment, to Evaluate the Efficacy of Azithromycin in the Treatment of Children With Non Cystic Fibrosis Bronchiectasis ( AZI-STOP Study )Non Cystic Fibrosis Bronchiectasis in ChildrenDrug: AzithromycinAssistance Publique Hopitaux De MarseilleNULLActive, not recruiting3 Years17 YearsBoth100Phase 3NULL
6NCT02372383
(ClinicalTrials.gov)
October 201420/6/2014Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic FibrosisPharmacokinetic Evaluation of Nontuberculous Mycobacterial Antibiotics in Cystic Fibrosis Versus ControlsCystic FibrosisDrug: Ethambutol;Drug: Rifampin;Drug: Azithromycin;Drug: PancrelipaseUniversity of Colorado, DenverCystic Fibrosis Foundation Therapeutics;Colorado Clinical & Translational Sciences InstituteCompleted16 Years45 YearsBoth32N/AUnited States
7NCT02803944
(ClinicalTrials.gov)
September 201414/6/2016Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two YearsLong Term Effects of Azithromycin in Patients With Cystic Fibrosis Using the National DatabaseCystic FibrosisDrug: AzithromycinHospices Civils de LyonNULLCompleted7 YearsN/ABoth2055N/AFrance
8NCT02054156
(ClinicalTrials.gov)
June 20141/2/2014OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic FibrosisOPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis: The OPTIMIZE Multicenter, Placebo-Controlled, Double-Blind, Randomized TrialCystic FibrosisDrug: azithromycin;Drug: placebo;Drug: Tobramycin solution for inhalationBonnie RamseyNational Heart, Lung, and Blood Institute (NHLBI)Completed6 Months18 YearsAll221Phase 3United States
9NCT01270074
(ClinicalTrials.gov)
April 201223/12/2010Prevention of Bronchiectasis in Infants With Cystic FibrosisA Phase 3 Multi-centre Randomised Placebo-controlled Study of Azithromycin in the Primary Prevention of Radiologically-defined Bronchiectasis in Infants With Cystic Fibrosis.Cystic Fibrosis;BronchiectasisDrug: Azithromycin;Drug: Placebo controlThe University of QueenslandTelethon Kids InstituteCompleted6 Weeks6 MonthsAll130Phase 3Australia;New Zealand
10NCT03045198
(ClinicalTrials.gov)
March 20122/2/2017Effect of Azithromycin on Fatty Acids in CFEffect of Azithromycin on Lipoproteins and Docosahexaenoic Acid in Patients With Cystic FibrosisCystic FibrosisDrug: AzithromycinUniversity Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn)University of Bonn;University Hospital, FrankfurtUnknown status10 Years60 YearsAll20Phase 4NULL
11EUCTR2006-003275-12-NO
(EUCTR)
03/06/200927/03/2009Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin StudyScandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.
MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Zitromax
Product Name: Zitromax
Product Code: Zitromax
INN or Proposed INN: AZITHROMYCIN
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Copenhagen CF-centreNULLNAFemale: yes
Male: yes
250Phase 4Denmark;Norway;Sweden
12NCT00411736
(ClinicalTrials.gov)
May 200814/12/2006Scandinavian Cystic Fibrosis Azithromycin StudySupplementary Oral Azithromycin in Treatment of Intermittent Pseudomonas Aeruginosa Colonization in CF-patients With Inhaled Colistin and Oral Ciprofloxacin; Postponing Next Isolate of Pseudomonas and Prevention of Chronic Infection. A Prospective, Double-blinded, Placebo-controlled Scandinavian Multi-centre Study.Cystic FibrosisDrug: Study medication, azithromycin or placebo;Drug: Azithromycin or placebo tabletsRigshospitalet, DenmarkCystic Fibrosis Foundation TherapeuticsCompleted1 YearN/ABoth45Phase 4Denmark;Norway;Sweden
13EUCTR2006-003275-12-DK
(EUCTR)
23/05/200717/04/2007Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin StudyScandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.
MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Copenhagen CF-centreNULLNot RecruitingFemale: yes
Male: yes
250Phase 4Denmark
14NCT00431964
(ClinicalTrials.gov)
February 20072/2/2007Effect of Azithromycin on Lung Function in 6-18 Year-olds With Cystic Fibrosis (CF) Not Infected With P. AeruginosaMulti-center, Multi-national, Randomized, Placebo-Controlled Trial of Azithromycin in Subjects With Cystic Fibrosis 6-18 Years Old, Culture Negative for Pseudomonas AeruginosaCystic FibrosisDrug: azithromycin 250 mg tablets;Drug: placebo tabletsCF Therapeutics Development Network Coordinating CenterCystic Fibrosis Foundation TherapeuticsCompleted6 Years18 YearsAll263Phase 4United States;Canada
15NCT01463371
(ClinicalTrials.gov)
October 200628/10/2011Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With BronchiectasisEffects of Long-Term Azithromycin Treatment on Airway Oxidative Stress Markers in Patients With Stable Non-Cystic Fibrosis BronchiectasisBronchiectasisDrug: AzithromycinInstituto de Investigacion Sanitaria La FeSociedad Valenciana de NeumologíaCompleted16 Years80 YearsBoth30N/ASpain
16NCT00298922
(ClinicalTrials.gov)
February 20062/3/2006Azithromycin in Patients With CF, Infected With Burkholderia Cepacia ComplexPhase II, Randomized, Double Blind, Placebo-Controlled Trial of Azithromycin in Patients With CF, Chronically Infected With Burkholderia Cepacia ComplexCystic FibrosisDrug: Azithromycin;Drug: PlaceboSt. Michael's Hospital, TorontoCystic Fibrosis Foundation Therapeutics;PfizerActive, not recruiting19 YearsN/ABoth45Phase 2Canada
17NCT00153634
(ClinicalTrials.gov)
March 20048/9/2005Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF)Standard vs. Biofilm Susceptibility Testing in CFCystic Fibrosis;Chronic BronchitisDrug: IV amikacin;Drug: PO azithromycin;Drug: IV ceftazidime;Drug: PO ciprofloxacin;Drug: IV meropenem;Drug: IV piperacillin-tazobactam;Drug: IV ticarcillin-clavulanate;Drug: IV tobramycinSeattle Children's HospitalCystic Fibrosis Foundation TherapeuticsCompleted14 YearsN/ABoth75N/AUnited States
18EUCTR2006-003275-12-SE
(EUCTR)
07/07/2009Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin StudyScandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: Azithromycin
Product Name: azithromycin
Product Code: azithromycin
INN or Proposed INN: AZITHROMYCIN
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Copenhagen CF-centreNULLNAFemale: yes
Male: yes
250Phase 4Denmark;Norway;Sweden
19EUCTR2014-003023-22-FR
(EUCTR)
22/06/2015Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study)Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study) - AZI-STOP study bronchiectasis excluding cystic fibrosis in children;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: ZITHOMAX 40 mg/ml ENFANTS
Product Name: zithromax
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
Trade Name: ZITHROMAX 250 mg
Product Name: ZITHROMAX
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLENULLNot RecruitingFemale: yes
Male: yes
100Phase 3France